Operator Qualifications The Intelect RPW is intended exclusively for use by medical specialists and is only allowed to be used by qualified and instructed medical persons in a clinical environment. These specialists are expected to have practical knowledge of medical procedures and applications as...
Intelect® RPW Product Description The Intelect RPW is intended for the use in predominately non-sterile medical sites. The Intelect RPW allows for the treatment of indications with radial, pneumatically generated, low energy acoustic waves (shock waves) or pressure pulses. The Intelect RPW is a compressed air operated ballistic shock wave generator featuring high-precision ballistic components in its applicator for shock wave generation.
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FOREWORD Intelect® RPW D-20mm D-35mm Caution D-20mm: Avoid using the D-20mm transmitter with pressures levels exceeding 3 Bars on screen when not applying on a non-impact surface (body). Handset is at risk for damage. Caution D-35mm: Avoid pressure over 3 Bars on screen at all times with D-35mm Transmitter. Handset is at risk for damage.
GENERAL INFORMATION The Intelect RPW unit and the accompanying components and individual elements fulfill, as a unit, the currently valid safety standards and comply with the stipulations of IEC 60601-1 and the medical products regulations. For more information about the standards to which the...
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Specifically, if the ramp feature is turned on, the intensity increases to the full preset number of bars after one-third of the pulses have been given. For more information on the ramping feature available on the Intelect RPW unit, see pages 44-45.
SAFETY INSTRUCTIONS Intelect® RPW PRECAUTIONARY DEFINITIONS The precautionary instructions found in this section and throughout this manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment. The definition of these symbols are as follows: Explosion Hazard CAUTION Text with an “Explosion Hazard”...
(see page • Before use of the Intelect RPW, make sure you have read and adjust the number of pulses the transmitter emits. understood all information provided in this manual. Familiarity with •...
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This unit can radiate radio frequency energy and, if not installed • and used in accordance with the instructions, may cause harmful The Intelect RPW is not intended for the treatment of kidney stones. interference to other devices in the vicinity. However, there is no •...
If adjacent or stacked use is necessary, the In case of display failure or other obvious defects, switch Intelect RPW should be observed to verify normal operation in the the unit off immediately by means of the power on/off configuration in which it will be used.
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SAFETY INSTRUCTIONS Intelect® RPW WARNING WARNING • • The surface of the transmitter can become hot if the unit is used Remove the applicator by pulling the cable connector only. DO outside of the parameters listed on page 29. Therefore, the operator NOT remove by pulling the cable.
• Explosion hazard if the Intelect RPW is used in the presence • If the unit is not safe for operation, then it must be repaired...
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DANGER DANGER • • The Intelect RPW unit may contain Di (2-ethylhexyl) The effects of BPA and DEHP are not known in the phthalate (DEHP) which is the plasticizer for most PVC concentrations present in the unit and its applicators.
SAFETY INSTRUCTIONS Intelect® RPW PERSONAL SAFETY In case of improper or unauthorized use of the unit, the operator, Before using the unit, speak with the patient to verify: the patient or other persons may be subjected to the danger of •...
SAFETY INSTRUCTIONS Intelect® RPW PROTECTION OF THE UNIT WARNING Improper installation, operation or maintenance of the radial pressure wave unit may result in malfunctions of this unit or other devices. Before connecting the unit, make sure that: • The voltage rating on the safety label corresponds to the available system voltage.
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SAFETY INSTRUCTIONS Intelect® RPW PROTECTION OF THE UNIT (CONTINUED) Do not connect the unit to the Mains Power Supply until the following requirements have been met: • Before putting the unit into operation, check to make sure that the handset connection cable and the transmitters are undamaged and have been connected correctly to the unit.
ABOUT RADIAL PRESSURE WAVE THERAPY Intelect® RPW OVERVIEW • Radial shock waves (R-SW) are introduced into the body by means Shock waves stimulate nociceptors which, in turn, release a high amount of neural pulses. As described by the Gate of a freely moved applicator and cover the entire pain region. Radial Control Theory, transmission of these pulses to the central shock waves are often referred to as radial pressure waves, which is nervous system is inhibited.
ABOUT RADIAL PRESSURE WAVE THERAPY Intelect® RPW OVERVIEW (CONTINUED) Treatment results have demonstrated that shock wave therapy provides improved blood circulation in the treated pain regions and that a long term stimulation of metabolism is achieved in areas which, by nature, are poorly supplied with blood. Since repeated treatment sessions have shown to increase the beneficial effects of shock wave therapy, there is every reason to assume that shock waves also produce secondary effects as described in the hypothesis towards associative pain memory, for instance.
INDICATIONS Intelect® RPW GENERAL Pulse Vibration Massage Before a treatment with Radial Pressure Wave, a correct examination and diagnosis should be performed. Please stay current with the latest Soothing relief from muscle strain and stress. developments and medical publications on Radial Pressure Wave therapy for details on contraindications and side effects not known at the time of Disorder of Tendon Insertions manufacturing.
Swellings that still feel warm. therapy for details on contraindications and side effects not • Implants, areas where implants have been removed, known at the time of manufacturing. The Intelect RPW unit is damaged implants, and metal inclusions. contraindicated for the following: •...
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CONTRAINDICATIONS Intelect® RPW GENERAL (CONTINUED) • Occlusive vascular disease, such as arteriosclerosis obliterans and thromboangitis obliterans, in which organic occlusion and ischemia are evident. • In the presence of systemic or local infection (sepsis, Osteomyelitis, tuberculosis) or if the patient has an elevated temperature.
ADDITIONAL PRECAUTIONS Intelect® RPW GENERAL Possible Side Effects When administering radial pressure wave treatment, keep in mind the following: Side effects could occur after a treatment with Radial Pressure wave • Radial pressure wave treatment should be applied with therapy. The majority will appear after 1-2 days. caution over bone where minimal (bony prominence) or no Do not repeat a treatment until the previous side effects have (Stage IV wounds) soft tissue is present.
Remove the transport packaging upward. Intelect RPW unit • • Remove the remaining foam material. Intelect RPW CD User Manual • • Using at least 2 people, lift the unit from the lower packaging Intelect RPW Quick Start Guide element.
SETUP Intelect® RPW REQUIREMENTS FOR INSTALLATION Before the unit can be installed and put into operation, certain There is no need to plug the power cord into an isolated circuit for requirements must be fulfilled in the building where the unit is to the proper function of this unit.
NOMENCLATURE Intelect® RPW SOFTWARE SYMBOLS Display the Edit Treatment Screen Cancel and Return to Previous Screen Up Arrow (Increase) Change Text to Upper Case Change Text to Lower Case Down Arrow (Decrease) Radial pressure wave energy is being emitted Touch and Slide Left to Increase Massage therapy is being emitted Touch and Slide Right to Decrease Pause...
NOMENCLATURE Intelect® RPW ACCESSORIES Handpiece 1 . 20 mm Insert WARNING (Transmitter) 2 . Front Cap Keep all accessories and their cords separated during treatment by 3 . Rear Cap using the hook located on the side of the unit. Accessories or their 4 .
SPECIFICATIONS Intelect® RPW UNIT SPECIFICATIONS Ambient temperature ....+10 °C to 35 °C (50 °F to 95 °F) Relative Humidity ....5% to 90% NC (non-condensing) Air Pressure .
SPECIFICATIONS Intelect® RPW APPLICATOR SPECIFICATIONS Pay special attention to the list of contraindications. Refer to "Safety Instructions" on pages 7-12, "Contraindications" on pages 19-20, "Additional Precautions" on page 21, and "Personal Safety" page R-SW Handpiece Technical Data Compressed Air Output ....... . . 1.4 - 5 bar Frequency .
DESCRIPTION OF DEVICE MARKINGS The markings on the Intelect RPW system are your assurance of its conformity to the highest applicable standards of medical equipment safety and electromagnetic compatibility. One or more of the following markings may appear on the device:...
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SPECIFICATIONS Intelect® RPW DESCRIPTION OF DEVICE MARKINGS This icon is located adjacent the stop button and terminates the treatment Stop: Stops treatment This icon is adjacent to the start button and initiates the treatment. Starts: Starts treatment This icon is located directly above the treatment pause button and allows access to the clinical library.
This would open up a previously unknown potential for further therapeutic areas of application. Intelect RPW units are therefore used for a wide range of applications in hospitals and in private practices by doctors and physiotherapists.
OPERATION Intelect® RPW INSTALLING THE APPLICATOR Replacing and Installing the Transmitter 4 . Remove and replace the O rings on the transmitter if The handpiece is shipped fully assembled, but if the transmitter necessary. ever requires replacement, do the following: 1 .
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OPERATION Intelect® RPW INSTALLING THE APPLICATORS (CONTINUED) 6 . Press the front cap onto 8 . Align the red dot on the the rear cap and turn connector with the red dot the rear cap clockwise to on the socket and press the tighten it.
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OPERATION Intelect® RPW INSTALLING THE APPLICATORS (CONTINUED) WARNING • Do not cross cables. • To remove the cable from the handpiece, make certain the power is off. Hold the handpiece while removing the cable to prevent the handpiece from dropping to the floor. •...
OPERATION Intelect® RPW PREPARING THE UNIT FOR THERAPY DANGER The unit has been completely assembled in the factory and is ready for use except for connection of the handpiece and the power cord. The unit and the handpiece must be positioned so that there is no Proceed as follows in order to prepare the unit for operation: danger of personal injury.
OPERATION Intelect® RPW PREPARING THE PATIENT FOR THERAPY Before applying radial pressure wave to the patient, you must first prepare the patient’s skin. By properly preparing the patient’s skin for therapy, you will allow more energy to reach the targeted areas and reduce the risk of skin irritation.
OPERATION Intelect® RPW BASIC OPERATION 1 . Connect the male end of 4 . Press the Power On/Off the power supply cord to button or touch the LCD. an appropriate electrical The following occurs when outlet. the Power On/Off button is pressed or the LCD is touched: •...
OPERATION Intelect® RPW STARTING THERAPY Edit Treatment Screen The Intelect RPW offers the following methods from which you can begin a treatment session: 1 . On the Home Screen, press • Quick Link Indications (page button. The Edit • Home screen (page Treatment screen displays.
OPERATION Intelect® RPW STARTING THERAPY (CONTINUED) 4 . You may also increase and treatment. See "Select decrease parameters by Transmitter Screen" for pressing and sliding the more information on this button either left or right. feature. 5 . Press the Mode button 8 .
OPERATION Intelect® RPW STARTING THERAPY (CONTINUED) 2 . Press the transmitter to 6 . Press the button to highlight it, or press the return to the Home screen. buttons to scroll through a list of the Quick Link Indications available transmitters. By pressing the Quick Link Indications button on the Home screen, you can access specific pre-programmed indications, for general reference only, which aid in selecting the proper output and...
OPERATION Intelect® RPW STARTING THERAPY (CONTINUED) 2 . Press the START button on treatment. For example, you may have pressed the User Interface to begin the Low Back Pain button treatment. When the START which would cause the button is pressed, the Home screen to display the icon displays.
OPERATION Intelect® RPW STARTING THERAPY (CONTINUED) Using the Ramp Button 3 . When the START button and the trigger button on The Ramp button turns the ramping function on and off. Ramping the handpiece are pressed, the intensity serves to acclimate the patient to the pressure of the notice that the progress output instead of administering the full output all at once.
OPERATION Intelect® RPW STARTING THERAPY (CONTINUED) Using the Ramp Button to Stop the Ramping For example, if you set the intensity at 3.8 bar, and When using the ramping feature during a treatment session as you pressed the Ramp described in the previous section, the intensity can be stopped button before the intensity by pressing the Ramp button (the Ramp button will read "Ramp reached 3.8 bar, the rest of...
OPERATION Intelect® RPW STOPPING, PAUSING, AND COMPLETING THERAPY Stopping Therapy Using the STOP Button page 51 beginning with step 4. To stop therapy, press the STOP button on the User Interface. When the STOP button is pressed: If you choose to start •...
OPERATION Intelect® RPW STOPPING, PAUSING, AND COMPLETING THERAPY (CONTINUED) Pausing Therapy Using the Trigger Button If you choose to save the current parameters as a The therapy can be interrupted at any time by pressing the trigger user protocol, press the button on the handpiece.
OPERATION Intelect® RPW USING CLINICAL PROTOCOLS The indications contained in this section are to be used only as guidelines. Each patient should be individually assessed to determine the appropriateness of the parameter setting prior to use. 1 . Make sure the MMC 4 .
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OPERATION Intelect® RPW USING CLINICAL PROTOCOLS (CONTINUED) 8 . If you want to change 12 . Press the START button to the protocol (e.g. the begin treatment. recommended transmitter 13 . Press the trigger button to does not match the activate the handpiece.
RETRIEVING, DELETING, AND SAVING USER PROTOCOLS The Intelect RPW unit allows you to tailor a protocol according to the requirements of a patient. The treatment parameters selected at the home screen can be saved as a new user protocol or saved to replace a previously saved user protocol. You may create up to 200 user protocols.
OPERATION Intelect® RPW RETRIEVING, DELETING, AND SAVING USER PROTOCOLS (CONTINUED) 3 . Press the No button to 4 . To create a name for keep the user protocol the new protocol, press and return to the Retrieve the Save Protocol as a Protocol screen.
OPERATION Intelect® RPW RETRIEVING, DELETING, AND SAVING USER PROTOCOLS (CONTINUED) 2 . Press the 6 . Press the button to button save the new treatment to save the name of the parameters. A message protocol. A message displays to confirm the displays briefly to confirm overwriting of the old the protocol was saved.
OPERATION Intelect® RPW USING CLINICAL RESOURCES - EDUCATIONAL LIBRARIES The Educational Libraries can be accessed by pressing the button with the icon (Clinical Resources button) located below the touch screen display. The Clinical Resources screen allows you access to the Educational Libraries, Patient Card management, and Utilities screens. Anatomical Graphics Library 2 .
OPERATION Intelect® RPW USING CLINICAL RESOURCES - EDUCATIONAL LIBRARIES (CONTINUED) Handpiece Placement Library 4 . Press a button on the left side of the screen The Handpiece Placement Library serves as a guideline for the (Anatomical Images) to placement of transmitters for radial pressure wave treatment. display a list of either muscles or bones that 1 .
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OPERATION Intelect® RPW USING CLINICAL RESOURCES - EDUCATIONAL LIBRARIES (CONTINUED) 3 . Press one of the handpiece placement thumbnails to view the entire picture of the handpiece placement. The Handpiece Placement screen displays. 4 . Press the button to return to the previous screen.
OPERATION Intelect® RPW USING CLINICAL RESOURCES - EDUCATIONAL LIBRARIES (CONTINUED) Viewing Rationale Viewing Contraindications Pressing the Shockwave Rationale button displays an overview of Pressing the Contraindications button displays a list of conditions radial pressure wave, a list of available treatment options, and a for which radial pressure wave therapy is contraindicated.
OPERATION Intelect® RPW USING CLINICAL RESOURCES - PATIENT CARD The Patient Card buttons serve to manage the information stored on a patient's data card. NOTE: This button is only active when a patient card is inserted into the patient card port on the device. Viewing and Retrieving Treatments from the Patient 3 .
OPERATION Intelect® RPW USING CLINICAL RESOURCES - PATIENT CARD (CONTINUED) Editing the Pain Profile 2 . In the Pain Before Treatment section, press to The Edit Pain Profile button allows access to the screen for pain select either a Numeric or information to be saved to the patient card while a therapy session Visual pain scale.
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OPERATION Intelect® RPW USING CLINICAL RESOURCES - PATIENT CARD (CONTINUED) 7 . Press the Edit Pain Map 12 . Press the Treatment button. The Pain Map Area screen. The Select Before Treatment screen Treatment Area screen displays. displays. 8 . Press the body area on which you intend to administer therapy.
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OPERATION Intelect® RPW USING CLINICAL RESOURCES - PATIENT CARD (CONTINUED) 14 . Press the Save to Patient Card to save the pain information to the patient's card. 15 . Press the button to return to the Clinical Resources screen. 16 . Press the button to return to the Home screen.
OPERATION Intelect® RPW USING CLINICAL RESOURCES - PATIENT CARD (CONTINUED) Saving Treatments to the Patient Card If the treatment time expires during a treatment, or if you stop a treatment using the STOP button, the unit gives you the option of saving the treatment to a patient card.
OPERATION Intelect® RPW USING CLINICAL RESOURCES - PATIENT CARD (CONTINUED) Erasing Patient Card NOTE: By pressing the Yes button, you Use this button to remove all information on the Patient Card. will permanently remove all data on 1 . To delete all information on the Patient Card.
OPERATION Intelect® RPW USING CLINICAL RESOURCES - UNIT SETTINGS To access the Unit Settings screen, press the Unit Settings button on the Clinical Resources screen. The version number of the software appears at the top of the screen. Adding and Changing the Clinic Name 5 .
OPERATION Intelect® RPW USING CLINICAL RESOURCES - UNIT SETTINGS (CONTINUED) Setting the Date and Time Resetting Unit Settings This button resets settings such as the language, volume, and clinic 1 . On the Unit Settings name back to the original factory defaults. screen, press the Set Date and Time button.
OPERATION Intelect® RPW USING CLINICAL RESOURCES - UNIT SETTINGS (CONTINUED) Changing Languages Press the No button if you do not reset all the 1 . On the Unit Settings user protocols to the screen, press the Language default parameters. You button.
OPERATION Intelect® RPW USING CLINICAL RESOURCES - UNIT SETTINGS (CONTINUED) 2 . Press the transmitter to Notice that all the buttons are now in the new highlight it, or press the language you selected. buttons to scroll through a list of the available transmitters.
OPERATION Intelect® RPW USING CLINICAL RESOURCES - UNIT SETTINGS (CONTINUED) 6 . If you choose to use a NOTE: Projectiles and guide tubes should be changed after second handpiece during 1,000,000 pulses. therapy, repeat steps To display the pulse count, do the following: 1-5 for the Ch2 Default Transmitter button.
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OPERATION Intelect® RPW USING CLINICAL RESOURCES - UNIT SETTINGS (CONTINUED) 3 . Press the Reset All button to reset all the pulse counters to zero.
OPERATION Intelect® RPW TREATMENT TIPS Holding the Handpiece as a Pen The applicator is placed over the previously diagnosed pain region. To start and stop shock wave application, the trigger button The handpiece is held provided on the applicator must be pressed behind the rear cap.
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OPERATION Intelect® RPW TREATMENT TIPS (CONTINUED) Using Both Hands to Hold the Handpiece This way of holding the applicator is recommended for the treatment of pain confined to specific points.
TROUBLESHOOTING Intelect® RPW ERRORS Error Codes and Descriptions Error Description Error Description Code Code The Patient Card button was pressed, but no valid treatments The MMC is being accessed, but there is no MMC inserted into were found on the Patient Card. the MMC port.
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TROUBLESHOOTING Intelect® RPW ERRORS (CONTINUED) WARNING Error Description Code A button was pressed that accessed the MMC card (e.g., Radial In the event that an Error message or Warning appears beginning with Pressure Wave Rationale, Contraindications, etc.), but the MMC a 2 or 3, immediately stop all use of the unit and contact the dealer or inserted into the MMC port is not the correct MMC.
MAINTENANCE Intelect® RPW MAINTAINING THE INTELECT RPW Routine Maintenance 4 . After each patient use, clean the R-SW handpiece Keep in mind the following when maintaining the unit: (remove the front and rear • As the manufacturer, DJO is responsible for the safety and...
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MAINTENANCE Intelect® RPW MAINTAINING THE INTELECT RPW (CONTINUED) 6 . Wait until the unit is 8 . When cleaning the completely dry before transmitter, push aside operating it again. the spacer ring so that the interior cavity can be 7 . It is recommended that cleaned.
MAINTENANCE Intelect® RPW MAINTAINING THE INTELECT RPW (CONTINUED) 10 . Removing and Replacing the Water Bottle 4 . Hold the cap, turn the bottle counter clockwise, You must empty the water bottle at least once a week and when and remove the cap.
MAINTENANCE Intelect® RPW MAINTAINING THE INTELECT RPW (CONTINUED) Replacing the Projectile and Guide Tube 7 . Slide the water bottle back into the holding bracket. Projectiles and guide tubes should be changed after 1,000,000 pulses. To change the transmitter, do the following: 8 .
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MAINTENANCE Intelect® RPW MAINTAINING THE INTELECT RPW (CONTINUED) 3 . Unscrew the shaft from the 5 . The projectile may be handpiece by turning it laying inside the handle. counterclockwise. Place your hand over the hole in the handle and turn...
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MAINTENANCE Intelect® RPW MAINTAINING THE INTELECT RPW (CONTINUED) 6 . Slide the long end of the hex wrench through the hole in the guide tube. 7 . While holding the shaft with one hand, pull the guide tube out of the shaft with the other hand.
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MAINTENANCE Intelect® RPW MAINTAINING THE INTELECT RPW (CONTINUED) 11 . If necessary, replace the red 13 . Press the guide tube into sealing sleeve by pressing the shaft until it seats. it into the opening of the shaft until it hits the stop.
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MAINTENANCE Intelect® RPW MAINTAINING THE INTELECT RPW (CONTINUED) 15 . Insert the shaft into the 17 . Reattach the rear cap by handle and turn clockwise turning it clockwise and until snug. holding the handpiece. 18 . Plug in the unit and...
MAINTENANCE Intelect® RPW MAINTAINING THE INTELECT RPW (CONTINUED) DANGER Functional Test (Daily) When performing daily inspections of the unit, pay particular attention the following areas of potential damage: • Under no circumstances may liquid penetrate the openings on the unit (e.g. the connecting sockets of the handset cables).
Do not perform unauthorized repairs under any circumstances. Return unit to DJO for servicing. The Intelect RPW unit must be recalibrated if it is not operating within specifications after routine maintenance and safety inspections have been performed. It is recommended that all DJO radial pressure wave treatment products be returned to the factory or a certified servicing dealer for repairs or recalibration.
Intelect® RPW STANDARD ACCESSORIES REF. Description REF. Description 28668 Intelect RPW CD User Manual One of the following power cords: 28671 Intelect RPW Quick Start Guide 14679 US [18 AWG, 118 in (300 cm)] 4248 Conductor™ Transmission Gel-250 ml (8.5 oz) bottle...
Intelect® RPW DJO, LLC, ("Company") warrants that the Intelect RPW ("Product") is free of defects in material and workmanship. This warranty shall remain in effect for three years fom the date of original consumer purchase. If this Product fails to function during the three year warranty period due to a defect in material or workmanship, at the Company's Option, Company or the selling dealer will repair or replace this Product without charge.
Compliance Electromagnetic Environment - Guidance RF emissions The Intelect RPW uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby Group 1 electronic equipment CISPR 11...
TABLE 2: GUIDANCE AND MANUFACTURER’S DECLARATION–ELECTROMAGNETIC IMMUNITY The Intelect RPW unit is intended for use in the electromagnetic environment specified in the table below. The user of the Intelect RPW should assure that it is used in such an environment.
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TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Intelect RPW is used exceeds the applicable RF compliance level above, the Intelect RPW should be observed to verify normal operation.
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COMMUNICATIONS EQUIPMENT AND THE INTELECT RPW The Intelect RPW unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Intelect RPW can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Intelect RPW as recommended below, according to the maximum output power of the communications equipment.
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